The draft Procedures document is being reorganized to clarify the information NIOSH considers in its evaluations, including relevant animal studies. Because there is conflicting evidence about the hazard posed by botulinum toxins to the workers who handle these drugs, NIOSH is not proposing the placement of botulinum toxins on the List at this time and invites additional studies, data, and expert opinions pertinent to this issue in order to evaluate the botulinum toxins more fully. This count refers to the total comment/submissions received on this document as reported by Regulations.gov. This PDF is Furthermore, animal studies must be evaluated for the recovery/reversibility of effects and the pharmacological relevance of the species studied. Are these standard or commonly accepted definitions of 'low dose' exposure? Seven commenters asked questions and offered suggestions about the procedures themselves. These tools are designed to help you understand the official document has no substantive legal effect. NIOSH response: A drug may be removed from the List based on either a written request from an interested party or a change to the package insert. 7. Comments were invited on any topic related to the drugs reviewed by NIOSH for possible placement on the planned 2018 version of the List. Comment: Bacillus Calmette-Guerin (BCG) should be removed from the List. No new information has been reported that would meet the NIOSH criteria for a hazardous drug. Genotoxicity: Cited studies demonstrated genotoxicity in male rats at high doses (2 grams/kilogram). Comment: NIOSH should conduct or commission a meta-analysis or systematic review, “[i]n the absence of published literature synthesizing the body of clinical knowledge” about a specific drug. The President of the United States communicates information on holidays, commemorations, special observances, trade, and policy through Proclamations. Carcinogenicity/genotoxicity: Cited studies in the package insert demonstrated an increased incidence of tumors in hamsters and rats. The new drafts, entitled the Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings (Procedures) and the NIOSH List of Hazardous Drugs in Healthcare Settings, 2020 (List) are found in the Supplemental Materials tab of the docket and are available for public comment, as discussed above. . If the latter is the case, could a sentence be added to clarify that?”. Manufacturer recommendation: that females of reproduction potential use effective contraception during and for four months after completing therapy. Reg. The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), in the Department of Health and Human Services announces that the following draft documents are available for public comment: (1) NIOSH Procedures for Developing the NIOSH List of Hazardous Drugs in Healthcare Settings (Procedures); (2) NIOSH List of Hazardous Drugs in Healthcare Settings, 2020 (List… NIOSH should collaborate with healthcare to better understand the implications of identifying certain drugs as hazardous and the cost to implement USP <800>. 9. NIOSH response: The NIOSH List creates no legal obligation for its users; it is informational, not regulatory, in content. Changes to the List structure would place all drugs that meet the NIOSH definition of a hazardous drug and contain MSHI in the package insert and/or are classified by the National Toxicology Program (NTP) as “known to be a human carcinogen,” or classified by the International Agency for Research on Cancer (IARC) as “carcinogenic” or “probably carcinogenic” on Table 1. This drug poses no risk to healthcare workers; the evidence supporting its addition is not based on occupational exposure. After evaluating public comments, NIOSH made the following determination: 13 drugs are proposed for placement on the List, 3 drugs are automatically added to the List because they have MSHI in the package insert (2 drugs identified in the 2018 FRN and another recently-approved by FDA), 7 drugs proposed for placement on the List in the 2018 FRN are no longer considered in this action. Comment: Triazolam should not be placed on the List. See https://www.cdc.gov/niosh/topics/hazdrug/peer-review-plan.html for the peer review plan for the draft Policy and Procedures. . Peer review comment: NIOSH did not include a mechanism to place investigational drugs on the List. documents in the last year, 108 daily Federal Register on FederalRegister.gov will remain an unofficial Please note that all comments submitted through Beta, both d 4. . Agency: Centers for Disease Control and Prevention (CDC) , Fifty-seven submissions were received in docket CDC-2018-0004 (NIOSH-233-B) from 55 commenters (one commenter sent three separate submissions to the docket). In 2010, NIOSH first updated the List based on the NIOSH definition of a hazardous drug. Federal Register provide legal notice to the public and judicial notice New Documents the Federal Register. All three draft documents are available in the docket for this activity. publication in the future. B. Washington — NIOSH has extended until July 30 the comment period on three draft documents pertaining to hazardous drugs in health care. All are open for a 60 day comment period. .”. Relevant information about this document from Regulations.gov provides additional context. Peer review comment: NIOSH should clarify whether a drug may be removed from the List based on changes to the package insert, “or if written requests from interested parties to the NIOSH Director are the only mechanism for consideration of a drug for deletion from the List (the reconsideration process as described). The subsequent description of a site risk Start Printed Page 25441assessment does not seem appropriate here. Information of particular interest includes considerations for design and implementation of a medical surveillance program, data analysis, and communication of results to participants. Comment: FDA-approved drugs should be reviewed in real time or NIOSH should provide “off-cycle” updates to the List. However, after consideration of input from the public and stakeholders, NIOSH has decided to review the toxicity and the hazards related to occupational exposure to botulinum toxins. electronic version on GPO’s govinfo.gov. The List now comprises only two tables: Table 1: Drugs that contain MSHI in the package insert and/or meet the NIOSH definition of a hazardous drug and are classified by NTP as “known to be a human carcinogen,” or classified by IARC as “carcinogenic” or “probably carcinogenic.”, Table 2: Drugs that meet the NIOSH definition of a hazardous drug, but do not have MSHI and are not classified by NTP as “known to be a human carcinogen,” or classified by IARC as “carcinogenic” or “probably carcinogenic.”. Comment: The List seems to be heavily weighted toward older drugs.Start Printed Page 25444. Procedures for Developing the NIOSH List of Hazardous Drugs in … by the Comptroller of the Currency, the Federal Reserve System, and the Federal Deposit Insurance Corporation Barbara MacKenzie, NIOSH, Robert A. Taft Laboratories, 1090 Tusculum Avenue, MS-C26, Cincinnati, OH 45226, telephone (513) 533-8132 (not a toll free number), email: firstname.lastname@example.org. A new peer review was not conducted. The OFR/GPO partnership is committed to presenting accurate and reliable provide legal notice to the public or judicial notice to the courts. Moreover, caution should be taken when making determinations about potentially hazardous drugs because causality is not necessarily demonstrated by a strong association just as absence of causality is not necessarily demonstrated by weak associations; associations that demonstrate a monotonic trend in health outcome frequency (steadily increasing or decreasing without ever changing direction) are not necessarily causal if a confounding factor demonstrates a dose-response relationship with the health outcome; and prior beliefs should not be allowed to cloud judgment with regard to plausibility. NIOSH also sought comment on a draft Policy and Procedures for Developing the NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings (Policy and Procedures). Peer review comment: NIOSH's discussion of an employer-performed site-based risk assessment to control the risk of exposure is confusing when placed in a document describing NIOSH's hazard identification procedures. Because the way cancer is treated therapeutically has changed, and the types of drugs used to fight cancer have changed, antineoplastic drugs are no longer all cytotoxic, genotoxic, and highly hazardous chemicals. were derived. NIOSH response: NIOSH has not conducted a formal meta-analysis or systematic review for any drug currently on the List. Embryo-fetal toxicity is shown to happen at dose exposure 1.5 times the recommended ingested human dose of 80 mg; it is unlikely that a healthcare worker would accidentally be exposed to osimertinib during handling at levels found to cause embryo-fetal harm. Peer reviews on the draft Policy and Procedures, as well as NIOSH's responses, are discussed below. Federal Register issue. Public comments on the draft Policy and Procedures and the drugs proposed for placement on the List and peer review summaries on specific drugs proposed for placement on the List are available in dockets CDC-2018-0004 and NIOSH-233-B. When studies are available for review of a drug being considered for placement on the List or for the reevaluation of a drug already on the List, quality may be evaluated by NIOSH scientists and independent peer reviewers on a case-by-case basis. Because dosage forms can change and new dosage forms may be approved, dosage form is not considered in making List placement determinations. on FederalRegister.gov NIOSH response: A drug may be considered a hazardous drug but not a chemical carcinogen if, for example, a drug manufacturer includes a carcinogenicity warning in the drug's package insert but the evidence for carcinogenicity has not been reviewed by the International Agency for Research on Cancer (IARC); the National Toxicology Program (NTP), within the U.S. Department of Health and Human Services; the U.S. Environmental Protection Agency (EPA); or independently by NIOSH. Peer review comment: NIOSH should list further tools to aid employers to protect workers. NIOSH list of hazardous drugs in healthcare settings 2020. Data evaluation submitted to the docket by the manufacturer demonstrates that interferon beta-1b is not causally associated with spontaneous abortion or with any “patterns or signals suggesting pregnancy outcomes.” Research on Start Printed Page 25447populations who have received interferon beta-1b throughout pregnancy have demonstrated no difference in spontaneous abortions or birth weight compared to population comparators. The Federal Register Notice for the Draft of the 2020 NIOSH List of Hazardous Drugs is now available. What improvements could be made to this risk management information to make it more useful to employers and healthcare workers? documents in the last year, 746 documents in the last year, 769 Be sure to leave feedback using the 'Feedback' button on the bottom right of each page! NIOSH does not offer peer reviews for public comment for any scientific publications because the technical and scientific review conducted by independent peer reviewers are not NIOSH products. However, because NIOSH has reaffirmed in the draft Procedures that only those drugs approved by the FDA Center for Drug Evaluation and Research are included in the List, BCG is no longer included in the List. Comment: Peer reviews should be conducted before the close of the public comment period to allow public commenters time to review them. The large molecular size limits dermal absorption and aerosolization. For example, monoclonal antibodies “are too large to be absorbed through skin contact, and if ingested, they would be destroyed by digestion; if inhaled, the pulmonary system would prevent absorption. Only when a labeling change results in the addition of MSHI to a package insert will NIOSH automatically consider the drug to be a hazardous drug and add it to the List. For this reason, NIOSH encourages individual healthcare settings to develop their own formulary-specific lists of hazardous drugs, which could include investigational drugs that have not yet been approved by FDA. Similar questions were raised about animal studies. . As stated in the OMB Final Information Quality Bulletin for Peer Review (Bulletin), “[p]eer reviewers shall be charged with reviewing scientific and technical matters. One would assume that, in both instances, a great deal of time and thought is expected to provide feedback to NIOSH. documents in the last year, 235 Those monoclonal antibodies that are not directly cytotoxic or conjugated with a cytotoxic agent should be moved from Table 1 to another place on the List. 4. Please explain. This drug is administered as a coated tablet, self-administered by the patient at home; as such, ivabradine poses no risk to healthcare workers. NIOSH does not review biologics reviewed by the FDA Center for Biologics Evaluation and Research. documents in the last year, 929 On October 15, 2020, the FDA reissued the Emergency Use Authorization (EUA) for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China to … There are no human studies relating to the developmental effects of daratumumab or dinutuximab. Comment: Hazardous drugs should also be identified by UNII code (the unique ingredient identifier used by FDA and USP) on the List. Information about this document as published in the Federal Register. The most important criteria for the review of human studies are strength of association, temporality, plausibility, and biological gradient. Public comments on the draft Policy and Proceduresand the drugs proposed for Until the ACFR grants it official status, the XML Public comments on the drugs and drug class proposed for placement on the List in 2018 are summarized and answered below. Therefore, NIOSH no longer proposes to place osimertinib on the List. documents in the last year, 1471 Accordingly, NIOSH has determined that interferon beta-1b does not meet the criteria for a hazardous drug and is no longer proposing to place it on the List.
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